For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.

Device Description

Spectranetics laser atherectorny catheters consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. Both over-the-wire and rapid-exchange catheter configurations are available. Laser energy impinged on a blockage ablates, or debulks, the lesion material thus opening the vessel, permitting placement of devices used in vascular interventions.

Spectranetics laser catheters are supplied in several models having tip diameters between 0.9 mm and 2.5 mm, appropriate for interventional use in peripheral arteries. Both over-the-wire and rapid exchange models are available.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Spectranetics CLiRpath Excimer Laser Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table or section. However, it implicitly defines success metrics that can be interpreted as performance targets.

Performance Metric	Reported Device Performance	Acceptance Criteria (Implicit)
Successful crossing of lesions	79%	High success rate for crossing totally occlusive peripheral vascular disease that cannot be crossed with standard guide wires.
Overall procedural success	72%	High overall success in the procedure, addressing symptomatic infrainguinal lower extremity vascular disease.
Re-establishment of straight-line blood flow to the foot	79%	High success rate in restoring distal blood flow for limb preservation.
Serious adverse events	"more rare than those observed during a larger registry study of laser atherectomy in the arteries of the legs."	Low incidence of serious adverse events, comparable to or better than established procedures.
Biocompatibility	Confirmed in accord with ISO 10993 series	Met ISO 10993 standards.
Sterilization	Validated in accord with ISO 11135	Met ISO 11135 standards.
Package integrity	Initially validated, 100% visually verified	Maintained integrity.
Device integrity and functionality	Met or exceeded Spectranetics in-house requirements and ISO 10555-1	Met internal and external standards for catheter performance.

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: 47 patients.
Data Provenance: Retrospective or Prospective: The study is described as "patients were enrolled at investigational sites," which usually implies a prospective clinical study.
Country of Origin: United States, Germany, and Belgium.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide information on the number of experts or their qualifications for establishing ground truth within the clinical study. The "ground truth" for the clinical success metrics (lesion crossing, procedural success, blood flow re-establishment) would have been determined by the treating physicians and potentially confirmed by diagnostic imaging and patient outcomes.

4. Adjudication Method for the Test Set:

The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the clinical study's outcomes. Clinical outcomes are typically assessed by the treating physician and may be reviewed by an independent clinical events committee or core lab, but this detail is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical trial focused on the device's performance in patients, not on comparing human reader performance with and without AI assistance. The CLiRpath is a medical device (laser catheter), not an AI-powered diagnostic tool.

6. Standalone Performance Study:

Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was effectively done. The clinical study evaluated the CLiRpath catheter's performance in isolation as a treatment device, with human operators (physicians) using the device, but not as part of an AI system providing diagnostic or treatment recommendations. The reported metrics (lesion crossing, procedural success, blood flow re-establishment) are direct measurements of the physical device's capabilities when operated by a clinician.

7. Type of Ground Truth Used:

The ground truth for the clinical study was based on:

Clinical Outcomes Data: Successful crossing of lesions, overall procedural success, and re-establishment of straight-line blood flow to the foot are direct clinical outcomes observed and measured during the procedure and potentially post-procedure.
Adverse Event Data: Tracking of serious adverse events.

8. Sample Size for the Training Set:

The document does not mention a distinct "training set" for the clinical evaluation. The 47 patients constitute the test set for the performance evaluation of the device in a clinical setting. This is a medical device, not an AI model, so the concept of a "training set" for an algorithm is not applicable in this context.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" in the context of an AI algorithm, this question is not applicable to the CLiRpath device's evaluation as described. The "training" for such a device would be the extensive bench testing, qualification, and validation studies (mentioned under "BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING"), which established its adherence to manufacturing and design specifications.

Summary

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APR 2 7 2004

510(k) SUMMARY

SUBMITTER INFORMATION

A. Company Name: Spectranetics Corporation, Inc.
B. Company Address: 96 Talamine Court Colorado Springs, Colorado 80907 C. Company Phone: 719-633-08333 / 1-800-633-0960
D. Company Facsimile: 719 442 2248
E. Contact Person: Adrian Elfe Vice President Quality Assurance & Regulatory Affairs Compliance

DEVICE IDENTIFICATION

A. Device Trade Name: CLiRpath Excimer Laser Catheter
B. Device Common Name: Laser Catheter
C. Classification Name: Catheter, Peripheral, Atherectomy
D. Device Class: Class II (per 21 CFR 870.4875)
E. Device Code: MCW

IDENTIFICATION OF PREDICATE DEVICES

The Safe Cross Radio Frequency Total Occlusion Crossing System (IntraLuminal Therapeutics, Inc.), which received market clearance under 510(k) K031842, is the primary predicate device. Other predicate devices include: Rotablator Rotational Angioplasty Systems (Heart Technology, Inc.) cleared under 510(K) applications K901206 and K933328, the Frontrunner CTO Catheter (LuMend, Inc.) cleared inder 510(k) K023114, and the Silverhawk Peripheral Catherer System (Foxhollow) cleared under under 510(k) K024243.

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DEVICE DESCRIPTION

INTENDED USE

CLiRpath™ catheters are intended for use in ablating a channel in totally occlusive peripheral vascular disease (including the superficial femoral, popliteal and infrapopliteal arteries), for enhancing the potential for limb preservation.

COMPARISON TO PREDICATE DEVICES

Spectranetics laser catheters for peripheral use are substantially equivalent in form, fit. and function to four (4) predicate devices, which have received market clearance inder section 510(k) rules.

Each of the devices is a catheter, i.e. a piece of tubing with a working length of approximately 100 cm, and a diameter between 0.9 mm and 6.0 mm. The catheters communicate mechanical and/or radiant energy to an occlusion within a patient's arteries in the lower limbs. Communicated energy disrupts occlusive material, such as arterial plaque, and permits its removal either when the catheter is withdrawn, soch as patient's endoreticular system. The pathway opened by each of the devices from the the subsequent placement of other devices and interventions.

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BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING

Biocompatibility of component materials and finished CLiRpath devices has been confirmed in accord with the ISO 10993 series of standards, Biological Evaluation of Medical Devices. Spectranetics conducts and maintains valid ethylene oxide sterilization processes in accord with ISO 11135, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Package integrity is initially validated. and, in addition, visually verified for 100% of Spectranetics devices prior to transfer to finished goods inventory.

CLiRpath device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. All excimer laser CLiRopath gathleter models meet or exceed both Spectranetics in-house requirements, and requirements listed in ISO 10555-1, Sterile, Single-use Intravascular Catheters - Part 1: General Requirements.

CLINICAL STUDIES

Forty-seven (47) patients with distal peripheral arterial disease were enrolled at investigational sites in the United States, Germany, and Belgium. The CLIRpath step by step excimer laser catheter procedure successfully crossed 79% of lesingsm step in to crossing with conventional guidewires. Overall procedural success was achieved in 72% of the cases, and straight-line blood flow was re-established to the foot in 79% of the cases. Serious adverse events associated with CLiRpath step by step treatments were more rare than those observed during a larger registry study of laser atherectomy in the arteries of the legs.

CONCLUSION

Human clinical studies verified the safety and performance characteristics for Spectranetics CLiRpath excimer laser catheters for use in the treatment of peripheral arterial disease. In vitro laboratory tests, as well as qualification and validation studies, have confirmed that CLiRpath catheters meet manufacturing and design specifications. All of these data combined establish substantial equivalence to the predicate devices,

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Spectranetics Corpation c/o Mr. Neil Burris Senior Clinical Data Services Analyst 96 Talamine Court Colorado Springs, CO 80907

SEP 1 8 2013

Re: K040067

Trade/Device Name: CLiRpath Excimer Laser Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: March 23, 2004 Received: March 24, 2004

Dear Mr. Burris:

This letter corrects our substantially equivalent letter of April 27, 2004.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Zin.Z-

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7. Statement of Indication for Use

Indication for Use

510(k) Number (if known): K04000

Device Name: Spectranetics CLiRpath™ Excimer Laser Catheters

Indications for Use

For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.

Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana P. Schamel

(Division Sigil-Off) Division of Cardiovascular Devices

510(k) Number_k040067

Page 1 of 1

CORRECTED PAGE 38 - CLiRpath 510k #K0400067

Spectranetics, K040067/A 1 23 March 04

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).